Raypilot Quality Control Kit

Primary DI
07350007954053
Brand
Raypilot Quality Control Kit
Company
Micropos Medical AB (Publ)
Model
1
Catalog number
4005
Device description
Raypilot Quality Control Kit is aimed to be used for daily quality control prior to any treatment.
Published
2023-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203722000RayPilot SystemMicropos Medical AB2021-09-02IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350007954053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350007954053073500079540537350007954053

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy invasive marker lesion localization systemAn assembly of noninvasive devices intended to monitor the position of a patient's tumour/lesion relative to the isocenter of a radiation therapy system, to assist with their alignment during treatment planning or a therapeutic procedure. It localizes the position of invasive markers [e.g., electromagnetic (EM) signal transmitters, radiopaque markers] (not included) which have been introduced/implanted in or near the target site prior to treatment. It typically includes an EM receiver and dedicated software.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+46317608005info@micropos.se

Regulatory Flags#

DUNS number
350533316
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350007952202Raypilot Receiver120202025-03-12
07350007956026Raypilot System Cable160022025-03-12
07350007951045Raypilot Hypocath110042023-04-04
07350007951052Raypilot Viewcath110052023-04-04
07350007952219Raypilot Extension Plate120212023-04-04
07350007953049Raypilot Software130042023-04-04
07350007954060Raypilot Transmitter Tester140062023-04-04
07350007954077Raypilot Table Displacement Meter140072023-04-04
07350007956019Raypilot Transmitter Cable160012023-04-04
07350007956033Raypilot Power Box160032023-04-04
07350007956040Raypilot Matching Network160042023-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277411815Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
00850002461343BiomarC®Carbon Medical Technologies, Inc.IYE2024-07-23
00850002461350Carbon Bright ®Carbon Medical Technologies, Inc.IYE2024-07-23
00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700445Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700506Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700582Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700643Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700667Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701060Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701084Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701107Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701121Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701145Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701169Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701183Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701206Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701220Gold AnchorNaslund Medical ABIYE2023-01-23
B887001062X-MARK UltraIzi Medical Products, LLCIYE2022-07-18
B887001067X-MARK UltraIzi Medical Products, LLCIYE2022-07-18
B8870010010X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010020X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010030X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010070X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010080X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010090X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010210X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010220X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010230X-MARKIzi Medical Products, LLCIYE2022-06-17